BRUSSELS – India’s status as a top world supplier of generic medicines could be threatened by a free trade agreement its government is negotiating with the European Union, a new study has concluded. Separately, the World Customs Organization has abandoned its intellectual property rights enforcement group, replacing it with a non-policymaking information committee.

A draft of the proposed agreement, available here [1], put forward by EU officials recommends that it should incorporate a wide range of intellectual property issues. According to Carlos Correa, a professor in the University of Buenos Aires, at least two of the provisions in the draft could hamper access to affordable medicines for developing countries.

In an analysis of the accord, Correa concluded that it could require India to forbid the manufacture of generic versions of patented drugs for up to five years after the patents in question expire. While the official rationale behind the EU’s proposal is that such an extension would offer compensation for the time it has taken the patent-holder to obtain marketing authorisation for a particular drug, Correa argued that it would have adverse consequences for the poor as it would delay the reduction of drug prices.

Another provision would offer protection to test data submitted for the approval of branded medicines for a certain length of time (the precise duration has not yet been specified by EU officials). In effect, this would bar makers of generic drugs from using that data.

Until now India has been opposed to introducing such a form of data exclusivity, Correa noted, adding that the EU recommendations go beyond the scope of the key international IP law: the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.

The question of access to medicines was one of the main issues debated at a public meeting held in Brussels on 10 June, organised by several consumer and health action groups.

Peter Maybarduk from the Washington-based organisation Essential Action said that a number of studies have estimated that the costs of medicines can fall by between 40 percent and 80 percent once generic versions of patented drugs become available. Despite the health benefits associated with this reduction, he complained that a number of governments from industrialised countries have been pursuing an “enforcement agenda” which places greater emphasis on the profits of corporations than on public needs.
—–He cited the Anti-Counterfeit Trade Agreement (ACTA) that the EU, the US, Japan and Switzerland decided to negotiate in 2007 as an example of how several different IP issues are being conflated. There is no clear, universally-accepted definition of what constitutes counterfeiting, he suggested. Whereas the TRIPS agreement focuses on violations of trademarks, the World Health Organization is more concerned with deliberate attempts to mislead consumers about the safety of medicines.

Because of the confusion resulting from this lack of clarity, a number of fallacies have gained currency, he said. “Fallacy number one is that any infringement [of IP rights] can be loosely considered a counterfeit or a pirated good,” he added. “Fallacy number two is that similar remedies can be applied for infringements of distinct rights. And fallacy number three is that aggressively combating alleged IPR [intellectual property rights] infringements protects public health.”

Alexandra Heumber, an access to medicines campaigner for Doctors Without Borders/Médecins Sans Frontières, protested at the series of seizures of generic medicines that have occurred in EU ports in recent times. Seventeen seizures of generic medicines, almost all of which were being shipped from India, occurred in the Netherlands during 2008, according to information released by the Dutch authorities, while a similar seizure also took place in Germany’s Frankfurt Airport last month. In every instance, the medicines were destined for developing countries.

Heumber argued that EU rules set in 2003 give customs authorities the power to intercept legal medicines in cases where it is suspected that an infringement of a patent may have occurred. She urged the EU’s executive branch, the European Commission, to issue new guidelines making it clear that such seizures should not be applied to generic medicines.

“While the seizure of counterfeit drugs is understandable, the seizure of legitimate drugs in transit is not acceptable,” she said.

Patrick Ravillard, a trade official with the Commission, said that his institution does not “make any confusion between generic medicines and fake medicines.” Stating that the EU is committing to boosting access to medicines for the poor, he said that assurances have recently been given by Europe’s leading pharmaceutical firms that they will not invoke EU rules to request the seizure of generic drugs. Such assurances are “very positive,” he claimed.

James Love from the organisation Knowledge Ecology International attacked the lack of transparency surrounding the ACTA negotiations. Documents under discussion and even the names of those taking part in the talks have been withheld from the public. He also suggested that leaks from the talks indicate that the title ACTA is something of a misnomer. Rather than being confined to matters of counterfeiting, the talks are dealing with a variety of other intellectual property issues, with the EU even seeking to place geographical indications (terms such as Bordeaux or Champagne that belong to food or drink from particular locations) on the agenda.
WCO Scales Back Policymaking on IP Enforcement

Meanwhile, Brazilian diplomat Henrique Moraes said that public interest groups should be wary of a phenomenon known as “forum-shopping” by governments where IP issues that have been rejected in one institution appear on the agenda of another.

The little-known World Customs Organization, he noted, has been discussing proposals aimed at allowing customs authorities throughout its 174 member countries to seize goods in transit when it is suspected that patents may have been breached. Such provisions went beyond the scope of TRIPS, he added.

Protests raised by Brazil and some other developing countries appear to have paid dividends, he added. During discussions held last week, it was agreed that the WCO will replace its working group known as SECURE (Standards to be Employed by Customs for Uniform Rights Enforcement) with a new internal body. Unlike SECURE, its successor, the counterfeiting and piracy group, will be restricted to exchanging information on how customs officials deal with IP issues and will not have a mandate to set norms or decide on best practices.